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Levicept's LEVI-04 Shows Promise in Phase II Trial for Knee Osteoarthritis

• Levicept's LEVI-04, a novel p75NTR-Fc fusion protein, demonstrated substantial improvements in pain and function in patients with knee osteoarthritis in a Phase II trial. • The Phase II study enrolled 518 participants and was a multi-arm, multicenter, randomized, double-blind, placebo-controlled trial. • LEVI-04 inhibits NT-3 activity and restores neurotrophin homeostasis, offering a potential new treatment option for osteoarthritis patients. • Detailed results from the Phase II trial will be presented at the ACR Convergence 2024 on November 19, highlighting the drug's efficacy and safety.

Levicept Ltd will present Phase II trial results for LEVI-04, a first-in-class treatment for osteoarthritis, at the American College of Rheumatology's ACR Convergence 2024. The oral presentation is scheduled for November 19 at 8:00 AM EST in Washington, D.C.
LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) designed to provide analgesia by inhibiting NT-3 activity and restoring neurotrophin homeostasis. It supplements the endogenous p75NTR binding protein to scavenge excess neurotrophins present in osteoarthritis.

Phase II Trial Details

The Phase II study (NCT05618782) was a multiple-arm, multicenter, randomized, double-blind, placebo-controlled trial involving 518 participants with pain and disability due to osteoarthritis of the knee. The trial aimed to evaluate the efficacy and safety of LEVI-04.
Professor Philip Conaghan MD, Director NIHR Leeds Biomedical Research Centre and Principal Investigator, stated, "We look forward to presenting more details of what were truly exceptional results from this robust and well-designed study... we believe LEVI-04 has the potential to offer a vital new treatment option to millions of patients in need."

Conference Presentation

The presentation, titled "LEVI-04, a novel neurotrophin-3 inhibitor, substantially improves pain and function without deleterious effects on joint structure in people with knee osteoarthritis: a randomised controlled Phase II trial," will be delivered by Professor Philip Conaghan MD. The abstract number is L15.

About LEVI-04

LEVI-04 represents a novel approach to treating osteoarthritis by targeting neurotrophin pathways. Osteoarthritis affects millions worldwide, and current treatments often have limitations in terms of efficacy and side effects. LEVI-04's mechanism of action offers a potential improvement over existing therapies by directly addressing neurotrophin imbalances in the osteoarthritic joint.
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[1]
Levicept to Present Phase II Data at ACR Convergence 2024 - BioSpace
biospace.com · Oct 28, 2024

Levicept Ltd to present Phase II trial results of LEVI-04, a novel osteoarthritis treatment, at ACR Convergence 2024 on ...

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